Celcuity Inc. (NASDAQ:CELC) Q4 2022 Earnings Call Transcript

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Alex Nowak: Absolutely. Makes total sense. Thanks for the update.

Brian Sullivan: You’re welcome.

Operator: Thank you. Our next question is from Boris Peaker with TD Cowen. Please proceed with your question.

Unidentified Analyst: Hey, thanks. This is Nick on for Boris. Just one for me. What data should we be looking for from the FACT-1 and FACT-2 trials that are going to report in the second half that will show that it has a positive effect, like what specific endpoints should we be focused on?

Brian Sullivan: Sure. So to the end point in those two trials is a pathological complete response rate, which is a measure of whether the tumor has been terminated in the patient. There’s a specific assessment to determine that. And so we have a statistical plan that this defines a benchmark that we need to beat in order to determine that we have a potentially significant result that would warrant a continuing the study, but also continuing towards additional evaluations.

Unidentified Analyst: Great. That’s it for me.

Brian Sullivan: Thank you.

Operator: Thank you. Our next question is from Gil Blum with Needham & Company. Please proceed with your question.

Unidentified Analyst: Hi. This is Rohit on for Gil. Thanks for taking our questions. Can you just talk about any preliminary discussions you might have had with the payers? And if you received any feedback or possible pricing dynamics? Thanks.

Brian Sullivan: We have had discussions with payor consultants to get some perspective on the landscape. We have in our plan to initiate those kind of conversations as we get closer to the end of the year. But they are fairly well established benchmarks for prices that have been established with novel targeted therapies. The CDK4/6 therapies have been on the market and have an established price that’s been supported over time. Those novel that was just approved, PI3K drug has been approved and established price points. And so our internal assumptions assume — rather internal assumptions — when we drive a peak revenue estimate assume that our pricing will be at least comparable to, let’s say, what peak rate is obtaining in the marketplace. And we frankly think if our data is favorable that we will generate a greater clinical benefit for those patients and would certainly warrant at least an equivalent price.

Unidentified Analyst: Thank you.

Operator: Thank you. Our next question is from . Please proceed with your question.

Unidentified Analyst: Thank you. This is from H.C. Wainwright. Good afternoon, Brian. Just a quick question. This is — just trying to think beyond VIKTORIA-1 at this point. Certainly, this is a study where you’re combining with the CDK4/6 inhibitor. Are there any thoughts in terms of combination with other immune checkpoint inhibitors because that’s also being floor as a way to go in breast cancer?

Brian Sullivan: So immune checkpoint inhibitors to date have been approved in TNBC, triple-negative breast cancer. There haven’t been successful results in HR-positive hormonally driven breast cancer as a case in prostate cancer. So it appears, at least the data to date suggests that hormonally-driven cancers are not responsive to the checkpoint inhibitors. And that certainly is a factor that we take into account as we’re considering our development plan.

Unidentified Analyst: Thank you. Thanks for taking my question.

Brian Sullivan: You’re welcome.

Operator: There are no further questions at this time. I would like to turn the floor back over to Chief Executive Officer, Brian Sullivan for closing comments.

Brian Sullivan: Well, thank you again for participating in our call today and for your ongoing support. We’ll be participating in the Needham Healthcare Conference in mid-April. Look forward to meeting with many of you there. I hope you have a great evening.

Operator: This concludes today’s teleconference. You may disconnect your lines at this time. Thank you for your participation.

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